Herpes testing: Focus Diagnostics’ gets FDA nod to add genital swab to Simplexa™ HSV 1 & 2 Direct Molecular Test
by Staff from Outbreak News Today on (#KASE)
Quest Diagnostics, the world's leading provider of diagnostic information services, today announced that its Focus Diagnostics products business has received FDA 510(k) clearance to add the genital swab claim to its Simplexa HSV 1 & 2 Direct molecular test on the Integrated Cycler. The new labeling clearance follows FDA's de novo 510(k) clearance and CLIA ["]
